MAUDE Adverse Event Report: AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY AN OWENS & BIOPSY PACK; CUSTOM BIOPSY TRAY

Model Number MTHD-010-03

Device Problems Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2016

Event Type  malfunction  

Event Description

A biopsy kit was opened to do a procedure and when the wrapper was open there was a orange/ rust color stain on the tray and one of the items.Not sure if it is betadine or some other material that got into the tray.Technician had to retrieve another tray while patient was on table.

• Brand Name: BIOPSY PACK
• Type of Device: CUSTOM BIOPSY TRAY
• Manufacturer (Section D): AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY AN OWENS &; 9000 westmont dr.; stonehouse commerce park; toano VA 23168
• MDR Report Key: 6157611
• MDR Text Key: 61896798
• Report Number: 6157611
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MTHD-010-03
• Device Lot Number: 1140262
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1